Drug information for ABACAVIR SULFATE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION; ORAL 20MG Tentative Approval   ABACAVIR SULFATE abacavir CIPLA LIMITED 78348
2011-02-18 Letter
TABLET; ORAL 60 MG Tentative Approval  (Reference Drug) ABACAVIR SULFATE abacavir MATRIX LABS LTD 200733
2010-12-03 Letter
TABLET; ORAL 60MG Tentative Approval   ABACAVIR SULFATE abacavir AUROBINDO PHARMA 22293
2008-09-16 Letter
TABLET; ORAL 60MG Tentative Approval   ABACAVIR SULFATE abacavir CIPLA LIMITED 22547
2011-03-08 Letter
TABLET; ORAL 300MG Tentative Approval   ABACAVIR SULFATE abacavir CIPLA LIMITED 78119
2006-11-07 Letter
TABLET; ORAL 300MG Tentative Approval   ABACAVIR SULFATE abacavir MATRIX LABS 78742
2007-04-20 Letter
TABLET; ORAL 300MG Tentative Approval   ABACAVIR SULFATE abacavir STRIDES ARCOLAB LTD 91050
2010-05-17 Letter
TABLET; ORAL 300MG Tentative Approval   ABACAVIR SULFATE abacavir MYLAN PHARMA 91294
TABLET; ORAL 300MG Tentative Approval   ABACAVIR SULFATE abacavir INVAGEN PHARMS 91560
2010-10-04 Letter

Drug Adverse Effects information for ABACAVIR SULFATE

Role code Indications Reaction # Reports
PS PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 1
SS ANTIRETROVIRAL THERAPY CACHEXIA 8
SS ANTIRETROVIRAL THERAPY CHRONIC FATIGUE SYNDROME 8
SS ANTIRETROVIRAL THERAPY DEPRESSION 8
SS ANTIRETROVIRAL THERAPY DYSLIPIDAEMIA 9
SS ANTIRETROVIRAL THERAPY FACIAL WASTING 8
SS ANTIRETROVIRAL THERAPY HYPOAESTHESIA 8
SS ANTIRETROVIRAL THERAPY LIPODYSTROPHY ACQUIRED 8
SS ANTIRETROVIRAL THERAPY TYPE 2 DIABETES MELLITUS 9
SS ANTIRETROVIRAL THERAPY VASODILATATION 8
SS HAEMORRHAGE DIZZINESS 2
SS HAEMORRHAGE FIBRIN DEGRADATION PRODUCTS INCREASED 2
SS HAEMORRHAGE HEPATIC FUNCTION ABNORMAL 2
SS HAEMORRHAGE INFLUENZA LIKE ILLNESS 2
SS HAEMORRHAGE NAUSEA 2
SS HAEMORRHAGE NERVOUS SYSTEM DISORDER 2
SS HAEMORRHAGE PALPITATIONS 2
SS HAEMORRHAGE PULMONARY HYPERTENSION 2
SS HAEMORRHAGE TREMOR 2
SS HAEMORRHAGE VISUAL IMPAIRMENT 2
SS HEPATITIS C DIZZINESS 4
SS HEPATITIS C FIBRIN DEGRADATION PRODUCTS INCREASED 4
SS HEPATITIS C HEPATIC FUNCTION ABNORMAL 4
SS HEPATITIS C INFLUENZA LIKE ILLNESS 4
SS HEPATITIS C NAUSEA 4
SS HEPATITIS C NERVOUS SYSTEM DISORDER 4
SS HEPATITIS C PALPITATIONS 4
SS HEPATITIS C PULMONARY HYPERTENSION 4
SS HEPATITIS C TREMOR 4
SS HEPATITIS C VISUAL IMPAIRMENT 4
SS HIV INFECTION DIZZINESS 28
SS HIV INFECTION FIBRIN DEGRADATION PRODUCTS INCREASED 28
SS HIV INFECTION HEPATIC FUNCTION ABNORMAL 28
SS HIV INFECTION INFLUENZA LIKE ILLNESS 28
SS HIV INFECTION NAUSEA 28
SS HIV INFECTION NERVOUS SYSTEM DISORDER 28
SS HIV INFECTION PALPITATIONS 28
SS HIV INFECTION PULMONARY HYPERTENSION 28
SS HIV INFECTION TREMOR 28
SS HIV INFECTION VISUAL IMPAIRMENT 28
SS HYPERTENSION DIZZINESS 4
SS HYPERTENSION FIBRIN DEGRADATION PRODUCTS INCREASED 4
SS HYPERTENSION HEPATIC FUNCTION ABNORMAL 4
SS HYPERTENSION INFLUENZA LIKE ILLNESS 4
SS HYPERTENSION NAUSEA 4
SS HYPERTENSION NERVOUS SYSTEM DISORDER 4
SS HYPERTENSION PALPITATIONS 4
SS HYPERTENSION PULMONARY HYPERTENSION 4
SS HYPERTENSION TREMOR 4
SS HYPERTENSION VISUAL IMPAIRMENT 4
C ALCOHOLIC LIVER DISEASE DIARRHOEA 4
C ALCOHOLIC LIVER DISEASE RENAL FAILURE ACUTE 4
C ALCOHOLIC LIVER DISEASE RHABDOMYOLYSIS 4
C ASCITES DIARRHOEA 3
C ASCITES RENAL FAILURE ACUTE 3
C ASCITES RHABDOMYOLYSIS 3
C EPILEPSY FALL 1
C EPILEPSY SOMNOLENCE 1
C EPILEPSY SUICIDAL IDEATION 1
C HEPATITIS C CHOLECYSTECTOMY 1
C HEPATITIS C CHOLELITHIASIS 1
C HEPATITIS C PANCREATITIS 1
C HIV INFECTION ASTHENIA 7
C HIV INFECTION CHOLECYSTECTOMY 1
C HIV INFECTION CHOLELITHIASIS 1
C HIV INFECTION CRANIOCEREBRAL INJURY 4
C HIV INFECTION DEEP VEIN THROMBOSIS 7
C HIV INFECTION DIARRHOEA 7
C HIV INFECTION ELECTROENCEPHALOGRAM ABNORMAL 4
C HIV INFECTION FALL 4
C HIV INFECTION FIBRIN D DIMER INCREASED 2
C HIV INFECTION HIV TEST POSITIVE 4
C HIV INFECTION HYPOKINESIA 4
C HIV INFECTION INJECTION SITE ERYTHEMA 2
C HIV INFECTION INTERNATIONAL NORMALISED RATIO INCREASED 2
C HIV INFECTION MAJOR DEPRESSION 4
C HIV INFECTION NAUSEA 7
C HIV INFECTION OEDEMA PERIPHERAL 7
C HIV INFECTION PAIN IN EXTREMITY 7
C HIV INFECTION PANCREATITIS 1
C HIV INFECTION PHLEBITIS 2
C HIV INFECTION PHLEBOTOMY 4
C HIV INFECTION PULMONARY EMBOLISM 2
C HIV INFECTION RENAL FAILURE ACUTE 7
C HIV INFECTION RHABDOMYOLYSIS 7
C HIV INFECTION SOMNOLENCE 4
C HIV INFECTION SUICIDAL IDEATION 4
C HIV TEST POSITIVE FALL 4
C HIV TEST POSITIVE SOMNOLENCE 4
C HIV TEST POSITIVE SUICIDAL IDEATION 4
C PNEUMOCYSTIS JIROVECI PNEUMONIA DIARRHOEA 1
C PNEUMOCYSTIS JIROVECI PNEUMONIA RENAL FAILURE ACUTE 1
C PNEUMOCYSTIS JIROVECI PNEUMONIA RHABDOMYOLYSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION CHOLECYSTECTOMY 2
C PRODUCT USED FOR UNKNOWN INDICATION CHOLELITHIASIS 2
C PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 2
C PRODUCT USED FOR UNKNOWN INDICATION FALL 6
C PRODUCT USED FOR UNKNOWN INDICATION PANCREATITIS 2
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 2
C PRODUCT USED FOR UNKNOWN INDICATION RHABDOMYOLYSIS 2
C PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 6
C PRODUCT USED FOR UNKNOWN INDICATION SUICIDAL IDEATION 6
C PULMONARY ARTERIAL HYPERTENSION ABDOMINAL PAIN 1
C PULMONARY ARTERIAL HYPERTENSION CONSTIPATION 1
C SYPHILIS DIARRHOEA 1
C SYPHILIS RENAL FAILURE ACUTE 1
C SYPHILIS RHABDOMYOLYSIS 1
C TOXOPLASMOSIS PROPHYLAXIS DIARRHOEA 1
C TOXOPLASMOSIS PROPHYLAXIS RENAL FAILURE ACUTE 1
C TOXOPLASMOSIS PROPHYLAXIS RHABDOMYOLYSIS 1
C TYPE 1 DIABETES MELLITUS FALL 2
C TYPE 1 DIABETES MELLITUS SOMNOLENCE 2
C TYPE 1 DIABETES MELLITUS SUICIDAL IDEATION 2
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